1. Field of the Invention
This invention relates to a connector for therapeutic tubing and to a medical solution bag device using the connector. More particularly, this invention relates to a connector for therapeutic tubing used in dialysis and transfusion of solution and blood, which permits two tubes to be smoothly and easily connected with perfect water tightness and further enables the connected tubes to be unbreakably locked so that the tubes so connected and locked may be a perfect barrier against invasion of microorganisms into the tubing no matter how often the tubes may have been separated and reconnected by this connector for continuous therapy over a long period and to a medical solution bag device, particularly transfusion bag means proper for peritoneal dialysis, using the connector.
2. Description of Prior Art
The tubing used for therapy by dialysis or transfusion of medicinal solution or blood is liable to be invaded by microorganisms when two tubes or one tube and a bag constituting the tubing are connected to each other. For the safety of the therapy, therefore, protection of the tubing against the microorganic invasion poses itself an important technical task. In the therapy by transfusion of blood, if microorganisms steal their way through a point of connection into the tubing and invade the blood vessels, the white blood corpuscles which have an ability to eat microorganisms will make the microorganic invasion scarcely menacing so long as the number of microorganisms participating in the invasion is small. In the therapy by dialysis, particularly peritoneal dialysis which is directed to the regons within the abdominal cavity which are totally destitute of defense against microorganic attacks, safe protection of the tubing used in the therapy against the microorganic invasion constitutes one absolutely essential technical task. The recent therapy by peritoneal dialysis is less complicated in mechanism and construction and notably less expensive than the conventional therapy by dialysis using an artifical kidney. Medical science has substantially elucidated the causes for peritoneal adhesion. Thus, the therapy of the latest development is capable of effectively precluding the peritoneal adhesion and lightening the burden on the patient to a great extent. Besides, a system for continuous ambulatory peritoneal dialysis which enables the patient to engage normally in his daily work and, at the same time, receive continued therapy has been invented and adapted perfectly for practical use. Thus, the therapy by peritoneal dialysis has come to reawaken and arrest deep interest. The reliability of this particular method of dialysis regarding the safety of patient depends on the question as to whether or not the microorganic invasion of the tubing used in the dialysis can be perfectly prevented and, consequently, the plight of complicated peritonitis due to propagation of microorganisms within the peritoneum can be precluded. Unfortunately, it is held that the method of dialysis in its existing level is not capable of prolonged use.
The conventional method for continuous ambulatory peritoneal dialysis will be specifically described below. A catheter is surgically inserted into the abdominal cavity of a patient. A connector is attached to the external end of this catheter. With this connector, the other connector attached to the free end of a transfusion tube is coupled. Injection of a dialytic solution into the abdominal cavity is accomplished by hanging a bag containing the dialytic solution from a place higher than the abdominal cavity, piercing into the discharge port of the bag a bag syringe attached to the leading end of the transfusion tube, and loosening a clamp attached halfway along the length of the tube and fastened to plug or stop up the passage within the tube. After the injection of the dialytic solution into the abdominal cavity is completed, the aforementioned clamp is tightened on the tube and the tube is properly rolled into a coil, and the bag is stowed neatly at the waist of the patient. The patient is now free to walk around and engage in his normal work. After lapse of a stated length of time, the spent dialytic solution is withdrawn from the abdominal cavity. This withdrawal is effected by extending the tube, placing the bag on the floor, for example, and loosening the clamp on the tube. Then, the bag syringe is pulled out of the bag and the bag now containing the spent dialytic solution is discarded. The next dialysis is effected by setting a new bag containing a fresh supply of dialytic solution at a high level and then piercing the bag syringe into the transfusion port of the new bag. This procedure is repeated for the third and following cycles of dialysis.
At present, whenever the connectors are coupled and the bag syringe is inserted into the discharge port of the bag in preparation for the first cycle of dialysis and each of the following cycles of dialysis, disinfecting operations such as immersing the connectors momentarily in the solution of an iodine-based bactericide and thoroughly wiping the tip of the bag syringe with the bactericide are executed in order to prevent microorganic invasion of the tube interior. The bactericide in the solution enters the patient's body, though in a very small amount, and acts as a harmful substance. Thus, the bactericide is not allowed to be used in a high concentration but is required to be used in an extremely low concentration.
There has also been proposed equipment for continuous ambulatory peritoneal dialysis using a solution container connected by a flexible tube to a patient's tube leading into the patient's abdominal cavity, which equipment comprises a flexible, foldable plastic container for dialytic solution provided with a transfer port extended therefrom, a flexible tube extended from the aforementioned transfer port and provided at the leading end thereof with a luer connector for connection to a luer connector attached to the patient's tube, and a breakable member provided in the aforementioned flexible tube and adapted to obstruct the flow of the solution within the tube until it is broken (Japanese Publication of Unexamined Patent Application No. 55-99257, corresponding to United Kingdom Patent Applications GB 2,040,379A and 2,063,684A). This equipment also requires the leading ends of the tubes to be immersed in the bactericide or wiped thoroughly with the bactericide before it is put to use. Therefore, this equipment has a similar disadvantage.
The disinfecting operations involved in the conventional devices, therefore, fall short of being justly called sterilization from the microorganic point of view. In fact, many cases of infection occur through connectors and bag syringes used after a lapse of about two months' time. In such cases, complication with peritonitis have been reported. At present, no effective measure is available for preventing this infection. Although the continuous ambulatory peritoneal dialysis proves to be a highly effective form of therapy as described above, it is held that this therapy cannot be safely performed for a long time.